The FDA's decision was based on results from the OASIS trial, in which the Revi tibial neurostimulator device demonstrated significant efficacy for treating urge urinary incontinence in women.
The FDA has granted a De Novo marketing authorization to the Revi System (formerly Renova iStim), a tibial neurostimulator device for men and women with urge urinary incontinence (UUI), according to BlueWind Medical, the developer of the device.1
The agency’s decision to allow BlueWind to market the device was based on results from the OASIS trial, in which Revi demonstrated significant efficacy for treating UUI in women. Specifically, 76.4% of patients had a 50% or higher reduction in incontinence episodes at 6 months. Additionally, the data at 12 months showed that among patients who completed the study, 82% had a ≥50% reduction in UUI episodes and half (49.6%)were 100% dry during a 3 consecutive day evaluation.1
The study researchers also reported that 74% of patients at 6 months and 80.1% of patients at 12 months experienced an improvement in urgency episodes and voids (P < .0001). Additionally, 84.6% of patients at 12 months experienced at least a 10-point improvement (minimal important difference) in health-related quality of life (P < .0001).2
"UUI is a debilitating, life-altering condition that impacts every aspect of a patient's life," Cindy L. Amundsen, MD, Roy T. Parker Distinguished Professor of Obstetrics and Gynecology, Division of Urogynecology, professor of Urology at Duke University School of Medicine, who is an investigator for the OASIS clinical trial, stated in a press release.1
“The OASIS safety and efficacy data support the Revi device as a new option for those living with the frustrations of UUI. Additionally, while patient management should be based on clinical guidelines, use of this therapy may be considered by a physician's assessment before patients fail or cannot tolerate more conservative therapy, which could make this single outpatient procedure available to a larger number of patients with UUI," added Amundsen.1
The prospective, single-arm, open-label OASIS study included 151 women with UUI who were enrolled in 23 centers in the United Stated and Europe. Of the total population, 139 patients completed the study.2
Patients had a mean 4.8 UUI episodes per day at implantation. Patients had to have at least 9 UUI episodes over a 7-day diary. Device activation occurred approximately 4 weeks after implantation, with patients performing daily stimulation treatments at home twice daily for approximately 30 minutes each session. The investigators collected voiding diaries, quality of life, and patient satisfaction questionnaires at 6 and 12 months after device activation.2
At 12 months, 91.6% of patients were compliant with the system, and 95% of patients reported being satisfied with the treatment.2
Regarding safety, all adverse events (AEs) were considered to be mild or moderate and there were no serious AEs, according to BlueWind.1
"The FDA granting of the De Novo request for Revi is a critical milestone that underscores BlueWind Medical's unwavering commitment to developing an innovative alternative treatment option for the millions living with this affliction," Dan Lemaitre, chief executive officer of BlueWind, stated in a press release.1 "As we embark on this exciting new chapter, we remain dedicated to our mission of improving the lives of the patients we serve by helping them regain control of their UUI symptoms."
1. BlueWind Medical's Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence. Published online August 17, 2023. Accessed August 22, 2023. https://www.prnewswire.com/news-releases/bluewind-medicals-revi-system-secures-us-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence-301903199.html?tc=eml_cleartime
2. Heesakkers J, Digesu A, Sutherland S, et al. Pivotal study of a novel wirelessly powered, patient tailored programmed, tibial neurostimulator for the treatment of patients with overactive bladder. Presented at: American Urological Association Annual Meeting, April 28-May 1, Chicago. Abstract LBA01-05